MAUDE Adverse Event Report: DEPUY MITEK LLC US GRYPHON¿ PEEK DS ANCHOR WITH PERMACORD¿SIZE 2, 36"; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	223149
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).Reporter is a j&j sales representative.Investigation summary: the complaint device has not returned, therefore unavailable for a physical evaluation.However, photos were provided.Upon visual inspection of the photos, the distal tip of the shaft was deformed.The anchor was not in the inserter.A manufacturing record evaluation was performed for the finished device lot number: 8l94725, and no nonconformances were identified.Based on the condition of the device , this complaint cannot be confirmed.The photo does not provide enough evidence to determine root cause.Physical evaluation should provide more information to discern a possible root cause.The possible root cause for the deformed condition could be attributed to excessive force may overload the tip and fatigue.Also, the tapping was off angle.As per ifu, establish the axial alignment of the inserter to the hole.Insert the anchor into the drilled hole (through the drill guide) to full depth by malleting on the inserter handle until the inserter laser line.Establish the axial alignment of the inserter to the hole.Insert the anchor into the drilled hole (through the drill guide) to full depth by malleting on the inserter handle until the inserter laser line.Establish the axial alignment of the inserter to the hole.Insert the anchor into the drilled hole.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.
Event or Problem Description
It was reported by sales rep that during a shoulder arthroscopy labral repair procedure on (b)(6) 2022, it was observed that the handle disengaged from the shaft inserter while attempting to pull out the inserter on the gryphon¿ peek ds anchor with permacord¿size 2, 36" device after fastening the anchor into bone.During in-house engineering evaluation of a photo provided by the customer, it was determined that the distal tip of the device shaft was deformed; and the anchor was not in the inserter.They used a kocker and mallet to disengage the shaft from the anchor.It was unknown if and how the procedure was completed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: GRYPHON¿ PEEK DS ANCHOR WITH PERMACORD¿SIZE 2, 36"
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16226408
• Report Number: 1221934-2023-00427
• Device Sequence Number: 20183312
• Product Code: MAI
• UDI-Device Identifier: 10886705024742
• UDI-Public: 10886705024742
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141259
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: 223149
• Device Catalogue Number: 223149
• Device Lot Number: 8L94725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2023
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown